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临床试验/EUCTR2014-001546-25-NL
EUCTR2014-001546-25-NL进行中(未招募)1 期

Short versus extended antibiotic treatment with a carbapenem for high-risk febrile neutropenia in hematology patients with Fever of Unknown Origin: a randomized multicenter open-label non-inferiority trial. - SHORT-trial

VU University Medical Center0 个研究点目标入组 240 人开始时间: 2014年11月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1.Patients with malignant hematological diseases being treated with cytotoxic chemotherapy or stem cell transplantation;
  • 2.High-risk neutropenia;
  • 4.Age 18 years or older;
  • 5.Written informed consent.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 220
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 20

排除标准

  • 1.Contraindications to use of imipenem-cilastatin or meropenem such as allergy, previous severe side-effects or previous microbiological cultures with carbapenem-resistant microorganism(s).
  • 2.Corticosteroid use =10 mg per day prednisolone or equivalent for more than 3 consecutive days during the previous 7 days.
  • 3.Clinically or microbiologically documented infection.
  • 4.Symptoms of septic shock (systolic blood pressure <90 mm Hg unresponsive to fluid resuscitation and/or oliguria (urine production <500mL/day).
  • 5.Previous enrollment in this study during the same episode of neutropenia.
  • 6.Any critical illness for which Intensive Care Unit treatment is required.
  • 7.Legal incompetency

研究者

发起方
VU University Medical Center

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